Apparatus and method for accessing a body site

ABSTRACT

A device and method of using the device to access a desired tissue site within a patient&#39;s body and separating a tissue specimen from the tissue site suitable for evaluation. The device includes a probe member having an arcuate tissue-cutting RF powered electrode secured to and distally spaced from the distal end of the probe and a small dimensioned distal extremity which when an inner lumen thereof is subjected to a vacuum, secured tissue for the specimen to the surface of the distal extremity. A circular tissue-cutting blade preferably secured to the distal end of a supporting tube is configured to rotate and move longitudinally along the shaft of the probe member effective to sever a tissue specimen from tissue secured to the surface of the distal extremity of the probe member. The supporting tube covers the separated specimen, and may be disposed within an accessing cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of patent application Ser. No.10/179,933, filed on Jun. 21, 2002 (now U.S. Pat. No. 6,758,848) whichis a continuation-In-part of patent application Ser. No. 09/717,176,filed Nov. 16, 2000 (now U.S. Pat. No. 6,497,706), all of whichapplications and patents are hereby incorporated herein by reference intheir entirety and from which priority is hereby claimed under 35U.S.C.§§119(e) and 120.

FIELD OF THE INVENTION

The present invention relates generally to the field of biopsy devicesand the methods of using such devices. More specifically, it relates toa device and method for accessing a targeted site of pathologicallysuspect tissue mass within a patient's body, so as to facilitate thetaking of a specimen of the tissue mass.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, such aspotentially cancerous tumors, it is usually desirable to perform abiopsy, in which a specimen of the suspicious tissue is removed forpathological examination and analysis. In many instances, the suspicioustissue is located in a subcutaneous site, such as inside a human breast.To minimize surgical intrusion into the patient's body, it is desirableto be able to insert a small instrument into the patient's body toaccess the targeted site and then extract the biopsy specimen therefrom.

After removing the tissue specimens, additional procedures may beperformed at the biopsy site. For example, it may be necessary tocauterize or otherwise treat the cavity which results from tissuespecimen removal to stop bleeding and reduce the risk of infection orother complications. Also, it may be advantageous to mark the site forfuture surgical procedures should pathological tests performed on thebiopsy specimen indicate surgical removal or other treatment of thesuspected tissue mass from which the specimen was removed. Such markingcan be performed, for example, by the apparatus and method disclosed andclaimed in co-pending U.S. patent application Ser. No. 09/343,975,filedJun. 30, 1999, entitled “Biopsy Site Marker and Process and Apparatusfor Applying It,” which is hereby incorporated by reference in itsentirety.

Electrosurgical techniques have been used in a variety of circumstances,including certain types of biopsy procedures. In electrosurgery, highfrequency electrical energy is applied through an active electrode topatient tissue. The electrical energy flows through the tissue from theactive electrode to a return electrode which is in contact with thepatent's tissue and which may be on the exterior of the patient's bodyor intracorporeally disposed. Typically, the return electrode isattached to the patient at a point remote from where the primary oractive electrode contacts the tissue. The tissue adjacent the primaryelectrode is ablated, to form an opening in the tissue. Anelectrosurgical biopsy instrument is disclosed and claimed in U.S.patent application Ser. No. 09/159,467 for “Electrosurgical BiopsyDevice and Method,” assigned to the assignee of the subject application,and which is hereby incorporated by reference in its entirety.

SUMMARY OF THE INVENTION

This invention is directed to a biopsy device that provides ready accessto a targeted tissue site within a patient's body and provides for theseparation and capture of a tissue specimen from the target tissue site.The biopsy device of the invention generally includes an elongated probehaving a proximal end and a distal end and an inner lumen extendingtherein which is configured to be in fluid communication with a vacuumsource. A small-dimensioned distal probe section is provided which hastransverse dimensions less than adjacent probe portions distal to thesmall-dimensioned section, and which has one and preferably a pluralityof apertures in a wall thereof in fluid communication with the probe'sinner lumen. A circular cutter is slidably disposed about the probemember and configured for rotation around, and translation along, theprobe. Such longitudinal translation may be for a partial length, andpreferably is for the entire length of the small-dimensioned distalprobe section. The cutting surface of the circular cutter is disposed ina plane which is generally transverse and preferably perpendicular tothe longitudinal axis of the probe.

The proximal end of the probe is configured to allow the inner lumen ofthe probe to be connected to a vacuum source, so that when a vacuum isapplied to the inner lumen, tissue adjacent to the small-dimensioneddistal probe section is pulled into contact with the distal probesection and thereby secures the tissue specimen to the distal probesection. With the tissue specimen secured to the distal probe section,the circular cutter may then be advanced distally, and preferably alsorotated, to thereby separate the tissue specimen from the surroundingtissue bed to which the tissue specimen is secured and supported. Theprobe and the tissue specimen secured thereto may then be withdrawn fromthe patient.

In a preferred embodiment of the invention, the biopsy device has athin, arcuate shaped distal electrode connected to the distal end of theprobe and spaced distally therefrom as disclosed in copendingapplication Ser. No. 09/477,255,filed on Jan. 4, 2000, and as disclosedin U.S. Pat. No. 6,331,166, both of which are incorporated by referenceabove. The distal arcuate electrode preferably lies in a plane that isparallel to and generally passes through a longitudinal axis of theelongated probe. The distal arcuate electrode preferably includes two ormore electrode portions configured to flex or move in radial directions,such as within the plane parallel to the longitudinal axis. The maximalchordal dimension of the distal electrode is typically at least as largeas the diameter of the distal end of the elongated probe, and ispreferably greater than the diameter of the distal end of the probe toensure that an opening made by the electrode is large enough to allowthe biopsy device to be readily advanced through the tissue to thetarget site and through the suspicious tissue that will form at leastpart of the tissue specimen. Moreover, the distal electrode makes aplanar cut through the desired specimen as it advances through tissue.Thus, when the circular cutter severs a specimen from supporting tissueas it advances over the small-dimensioned distal probe section, thespecimen is typically formed circumferentially around thesmall-dimensioned distal probe section. Where the specimen includes theplanar cut made by the distal electrode, the specimen may be split intotwo or more sections.

In a presently preferred embodiment, the biopsy device is provided withan access cannula, within which is disposed a supporting tube that isslidably disposed around and along a length of the probe. The supportingtube is disposed so as to cover at least part of the small-dimensioneddistal probe section during advancement through tissue. The circularcutter is preferably disposed on the distal end of the supporting tube,and is configured to rotate within and to move longitudinally within theaccess cannula; the circular cutter is also configured to extend beyondthe distal end of the access cannula, as it advances distally around thesmall-dimensioned distal probe. The access cannula may retract andadvance as necessary to expose or cover portions of the circular cutterand supporting tube. In distal configurations, the access cannula,circular cutter and supporting tube may cover at least part of andpreferably all of the small-dimensioned probe. When the access cannula,circular cutter and supporting tube are disposed in proximalconfigurations, at least a portion of the small-dimensioned probe may beexposed and configured to allow specimen tissue to be brought intocontact with the small-dimensioned distal probe section. A vacuum may beapplied to the inner lumen of the probe effective to pull tissue towardsthe small-dimensioned probe and to pull tissue into contact with thesmall-dimensioned probe where the specimen is secured. The circularcutter may be a separate member secured to or formed by the distal endof the supporting tube. Longitudinal translation of the circular cutterand supporting tube, preferably with rotation, is effective to separatea tissue specimen, or specimens, from the adjacent tissue. Thesupporting tube, with the circular cutter attached at its distal end,translates longitudinally at least partially within the access cannula,which serves to support and guide the supporting tube and cutter. Thecircular cutter and a distal portion of the supporting tube may extenddistally from a distal end of the access cannula during distaltranslation and preferably rotation of the circular cutter. The accesscannula also serves to shield and to protect body tissue from contactwith a portion of the supporting tube as it translates and preferablyalso rotates during cutting operation.

Distal translation of the supporting tube over the small-dimensioneddistal probe section effectively encloses and captures the severedtissue specimen(s) within the interior of the supporting tube.

After acquisition of a tissue sample, the biopsy device may be withdrawnfrom the patient, and once withdrawn, the specimen or specimen sectionsmay be removed from the distal probe section for subsequent pathologicalexamination. Alternatively, the probe, including the small-dimensioneddistal probe section and the cutter attached to the supporting tube maybe withdrawn, and samples recovered, while the access cannula remains inposition at least partially within a patient's body. The retention ofthe access cannula in place at least partially within a patient's bodyaids in the recovery of subsequent samples, and aids in the delivery ofmarkers, drugs, and the like to the location from which a tissuespecimen was obtained.

The distal electrode is connected by means of an electrical conductorwhich extends to the proximal extremity of the probe, preferably throughthe inner lumen of the probe to a source of high frequency, e.g.radiofrequency (RF), electrical power.

The probe, including the distal radiofrequency cutter, proximal circularcutter and the supporting tube, and optionally the access cannula, arepreferably configured for hand operation, or may be powered by a handunit connected to a suitable controller. The probe, or components of theprobe, including such components as the circular cutter and its attachedsupporting tube, the access cannula, and other components, arepreferably configured to be sterilizable and to be disposable.

These and other advantages of the invention will become more apparentfrom the following detailed description of the invention and theaccompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a removable biopsy device havingfeatures of the invention seated within a handle with the supportingtube of the device in an opened configuration.

FIG. 2 is a perspective view of the biopsy device shown in FIG. 1removed from the handle.

FIG. 3 is a perspective view of the biopsy device shown in FIG. 2rotated 180° about its longitudinal axis.

FIG. 4 is an enlarged perspective view of the distal section of thebiopsy device shown in FIG. 2 with the supporting tube in an openedconfiguration.

FIG. 5 is an enlarged perspective view of the distal section of thebiopsy device shown in FIG. 2 with the supporting tube in a closedconfiguration.

FIG. 6 is a longitudinal cross-sectional view of the device shown inFIG. 3 taken along the lines 6—6.

FIG. 7 is an enlarged longitudinal cross-sectional view of the distalsection of the device shown in FIG. 6.

FIG. 8 is a transverse cross sectional view of the device shown in FIG.7 taken along the lines 8—8.

FIG. 9 is a transverse cross sectional view of the device shown in FIG.7 taken along the lines 9—9.

FIG. 10 is a transverse cross sectional view of the device shown in FIG.7 taken along the lines 10—10.

FIG. 11 is an enlarged longitudinal cross-sectional view of the distalsection of the device shown in FIG. 6 rotated 90° from the view shown inFIG. 7.

FIG. 12 is an enlarged longitudinal cross-sectional view of the distalsection of the device as shown in FIG. 11 with the supporting tube in aclosed configuration.

FIG. 13 is a transverse cross sectional view of the device shown in FIG.11 taken along the lines 13—13.

FIG. 14 is a transverse cross sectional view of the device shown in FIG.12 taken along the lines 14—14.

FIG. 15 schematically illustrates an operative system embodying thedevices of the invention.

FIG. 16 is a transverse cross sectional view of the device shown in FIG.12 disposed within a tissue site and tissue at the site held against thesurface of the distal extremity by the action of a vacuum within theinner lumen of the probe.

FIG. 17 is a transverse cross sectional view of the device shown in FIG.15 with the supporting tube in a closed configuration with a separatedtissue specimen within the space between the distal extremity 20 and theinterior of the supporting tube 14.

FIG. 18 is a perspective view of an alternative probe member for thebiopsy device.

FIG. 19 is a transverse cross-sectional view of the biopsy device shownin FIG. 18 taken along the lines 19—19.

FIG. 20 is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as shown in FIG. 18, with the access cannulaand supporting tube in a closed configuration.

FIG. 21A is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 20, shown configured for insertioninto a patient's body.

FIG. 21B is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 21A, shown configured with theaccess cannula and supporting tube retracted.

FIG. 21C is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 21A, shown after advancement of thesupporting tube and access cannula and cutting of a tissue sample.

FIG. 21D is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 21A, showing portions of the deviceremoved from within the access cannula which remains in place in bodytissue.

FIG. 21E is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 21A, shown configured for removalof a tissue sample from the device.

FIG. 21F is a longitudinal cross-sectional view of a device embodyingfeatures of the invention as in FIG. 21A, shown after re-insertion intoa patient's body and configured for recovery of another tissue sample.

DETAILED DESCRIPTION OF THE INVENTION

Reference is made to FIGS. 1–14 which illustrate a biopsy device 10embodying features of the invention. The device 10 generally includes anelongated probe member 11, a tissue-cutting blade 12, a tissue-cuttingelectrode 13 and a supporting tube 14 carrying tissue-cutting blade 12.The tissue-cutting electrode 13 preferably includes at least twocomponents, as illustrated in FIG. 1, although it may be a single wireelectrode, as illustrated in FIG. 2. The supporting tube 14 is slidablydisposed about the probe 11 and is slidably disposed within accesscannula 19. In one embodiment of the invention shown in FIG. 1, thedevice 10 is a disposable device and is configured to be mounted on ahandle 15 which is configured to provide mechanical and electricalpower, vacuum, and control to the device. For example, a handle 15 maybe configured to provide mechanical power effective to power thelongitudinal translation, rotation, reciprocation, or other movement oftissue-cutting blade 12, supporting tube 14, or other movable element ofdevice 10. Alternatively, mechanical and/or electrical power may beprovided by housing 26, or by handle 15 and housing 26. As illustratedin the FIGS. 1, 3, and 6, handle 26 may include finger holders 37configured to receive a finger or thumb of an operator. Finger holders37 are configured to release housing 26 from handle 15 when they aresqueezed by an operator.

The probe member 11 has a proximal section 16 and a distal section 18.Proximal section 16 is configured for slidable disposition within theinner lumen 17 of the supporting tube 14. Proximal section 16 acts toguide supporting tube 14 and to protect tissue-cutting blade 12 as thesupporting tube 14 and cutter 12 translate and rotate around probe 11and within access cannula 19. Distal section 18 includes a distalextremity 20 which is configured to secure tissue from a tissue sitewhich is to form the specimen and an enlarged distal end 21 to which thetissue-cutting electrode 13 is secured. The probe member 11 may becylindrical, with a circular cross-section, or may have a square,rectangular, or other shaped cross-section.

As shown in FIGS. 4 and 5, tissue-cutting blade 12 and supporting tube14 are configured to translate longitudinally so as to expose distalextremity 20 when in a proximal configuration, and to cover distalextremity 20 when in a distal configuration. Distal extremity 20 may bepartially covered when tissue-cutting blade 12 and supporting tube 14are in configurations intermediate to those illustrated in FIGS. 4 and5, and may be more completely covered or exposed when tissue-cuttingblade 12 and supporting tube 14 are in configurations more distal orproximal to those illustrated in FIGS. 4 and 5. During such longitudinaltranslation, tissue-cutting blade 12 may rotate (in one or morerotational directions) and/or may reciprocate longitudinally. Inpreferred embodiments, tissue-cutting blade 12 remains separated by agap 38 from enlarged distal end 21 of probe 11 at its most distalposition (e.g., FIG. 20).

As shown in more detail in FIGS. 6–10, the probe member 11 is providedwith an inner lumen 22 which extends from the distal extremity 20 to aconnection member 23 on the proximal end 24 of the probe member 11 andwhich is in fluid communication with the plurality of aspiration ports25 provided on the distal extremity 20 of the probe member 11. Theproximal end 24 of the probe member 11 and the connection member 23 aresecured within the housing 26 as shown in FIG. 6.

The supporting tube 14 is slidably disposed about the proximal sectionof the probe member 11 and has a proximal end secured to a slidablecollar 27 within the housing 26. The collar 27 is provided with anconnector 28 (which may be an arm as in FIG. 2 or a gear as in FIG. 3)which is configured to seat within a receiving opening on a driver (notshown) provided in the handle 15. The collar 27 is configured to beslidably disposed within the housing so that the driver on the handlecan move the arm 28 and as a result translate the outer tubular sheathas shown by the arrow 30 in FIG. 2 between an opened and closedconfiguration. Supporting tube 14 is also configured to rotate around alongitudinal axis 29 as well as to translate longitudinally withinaccess cannula 19. Translation of the supporting tube 14 andtissue-cutting blade 12 may include reciprocation (i.e., alternateddistal and proximal translation) as well as rotation, as the supportingtube 14 and tissue-cutting blade 12 move generally in a longitudinaldirection.

As illustrated in FIG. 2, a housing 26 may be provided with distalprojection 31 and proximal projection 32 which are designed to tightlyseat within receiving openings (not shown) provided in the handle 15 toeffect a snap fit of the housing 26 within a recess 33 provided in theupper surface 34 of handle 15 as shown in FIG. 1. A second long recess35 is provided in the upper surface 34 of handle 15 which is contiguouswith recess 33 and which is configured to receive the connection member23 tightly enough to prevent accidental excursions out of the recess.Connection member 23 has an inner lumen in fluid communication with theinner lumen 22 of the probe member 11. Distal projection 31 may beconnected to collar 27 attached to supporting tube 14 so thatlongitudinal translation of proximal projection 32 towards distalprojection 31 causes accessing cannula 19 and supporting tube 14 to movedistally. In preferred embodiments, accessing cannula 19 and supportingtube 14 move longitudinally in concert, with supporting tube 14 free torotate within accessing cannula 19.

The tissue-cutting blade 12, which is circular and disposed about theprobe member 11, has a sharp edge that is preferably beveled to have asharp edge on the outer diameter of the circular blade, although a bladewith a leading edge on the inner diameter of a tube is also suitable.The tissue-cutting blade 12 is connected to and supported by the wall ofsupporting tube 14. This construction allows the tissue-cutting blade 12to travel longitudinally with the supporting tube 14 within accesscannula 19 over the distal extremity 20 of the probe member 11, and thusto extend out of access cannula 19. In this configuration, with thetissue-cutting blade 12 disposed distally to the end of the accesscannula 19, the tissue-cutting blade 12 is effective to cut a tissuespecimen from tissue held against the distal extremity 20 by the actionof a vacuum within the inner lumen 22 from the tissue site, and at thesame time to cover the separated tissue specimen with the supportingtube 14. The inner surface of supporting tube 14 may be coated (e.g.,with teflon) to reduce friction. In preferred embodiments, the innerdiameter of the supporting tube 14 proximal to the tissue cutting blade12 is greater than the inner diameter of the supporting tube 14 at theregion of contact between the tissue-cutting blade 12 and the supportingtube 14, providing greater volume for a tissue sample. Thus, thespecimen can be removed with device 10 from the patient with the same,or nearly the same, movement that severs the specimen from surroundingtissue. As shown in FIG. 3, the collar 27 and the gear 28 are configuredto drive and to translate the supporting tube 14 both rotationally andlongitudinally.

The tissue-cutting electrode 13 has an arcuate portion which is spaceddistally away from the distal end 21 and has a maximum chord (i.e.distance between the ends of the arcuate portion) which is preferablylarger than the maximum diameter of the distal end. The maximum width ofthe tissue-cutting electrode 13 is preferably about 20 to about 50%greater than the maximum outside transverse dimension of the distal end21 of the probe 11. The tissue-cutting electrode 13 can be spaceddistally from an outer surface of the distal end 21 by a distance ofabout 0.01 to about 0.05 inch, preferably about 0.02 to about 0.04 inch.As shown in FIGS. 6 and 7, the arcuate tissue-cutting electrode 13 isformed out of the distal extremity of electrical conductor 41. Theproximal end 42 of the conductor 41 is electrically connected via aconductor to an electrosurgical generator which can supply highfrequency electrical power.

The shaft of the device 10 which extends out from the housing 26 mayhave a length of about 3 to about 15 cm, preferably, about 5 to about 13cm, and more specifically, about 8 to about 9 cm for breast biopsy use.To assist in properly locating the shaft of device 10 during advancementthereof into a patient's body, (as described below), the distalextremity 20 of the probe 11, the access cannula 19, and the supportingtube 14 may be provided with markers at desirable locations that provideenhanced visualization by eye, by ultrasound, by X-ray, or other imagingor visualization means. An echogenic polymer coating that increasescontrast resolution in ultrasound imaging devices (such as ECHOCOAT™ bySTS Biopolymers, of Henrietta, N.Y.) is suitable for ultrasonicvisualization. Radiopaque markers may be made with, for example,stainless steel, platinum, gold, iridium, tantalum, tungsten, silver,rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides ofthese metals. In addition, the surfaces of the device in contact withtissue may be provided with a suitable lubricious coating such as ahydrophilic material or a fluoropolymer.

The proximal portion of the probe 11 generally has an outer dimension ofabout 3 to about 10 mm and a inside dimension of about 2 to about 6 mmand it may be desirable in some embodiments to have a close fit betweenthe proximal section of the probe 11 and the inner lumen 17 ofsupporting tube 14 to avoid a gap therebetween which can catch or snagon adjacent tissue during advancement through tissue and impedeadvancement. Similarly, it may be desirable in some embodiments to havea close fit between the supporting tube 14 and the access cannula 19, inorder to avoid a gap therebetween which can catch or snag on adjacenttissue during advancement through tissue and impede advancement.

The tissue-cutting blade 12 is preferably the sharpened edge of a metalsupporting tube 14, or a sharpened metal band ringing the distal end ofthe supporting tube 14, although any sharp blade attached to thesupporting tube 14 is suitable. The tissue-cutting blade 12 may be madefrom any strong, durable material that can hold a sharp edge, forexample, a hard biocompatible metal such as stainless steel, titanium,or other metals, alloys, and compounds. A tissue-cutting blade may alsobe made from ceramic, glass, or other material having suitable strengthand ability to maintain a sharp edge.

The tissue-cutting electrode 13 can be formed with generally conductivewire formed of metallic materials such as stainless steel, tungsten,titanium, molybdenum, and other metals and metal alloys, includingrefractory metals and alloys containing refractory metals. The shaftcomponents from which the probe 11 and supporting tube 14 are formed maybe conventional medical grade polymer materials such as, for example,polycarbonate and liquid crystal polymer (LCP), respectively.

In preferred embodiments, the supporting tube 14 is stainless steel.However, metals, ceramics, glasses, and other materials capable offorming a sharp edge are also suitable. For example, a supporting tube14 may be made with an epoxy-braid material. Although stainless steeland other metals are preferred, an advantage of forming a supportingtube 14 from epoxy-braid materials, or from other non-conductivematerials, is that capacitative coupling with electrical componentsconnected to the tissue-cutting electrode 13 is reduced. Where asupporting tube 14 is made from a such non-conductive materials, a metaltissue-cutting blade 12 may be attached to the distal end of thesupporting tube 14. Preferably, materials used in the construction of adevice 10 are sterilizable, and suitable for use in disposable medicalinstruments.

The biopsy device 10 may be used to obtain a tissue specimen utilizingthe operation system 50 schematically shown in FIG. 15. The operatingsystem 50 generally includes a high frequency (e.g. RF) electrical powergenerator 51, which is electrically connected to the tissue-cuttingelectrode 13 on the biopsy device 10 through conductors 52 and 53. Thepower output and the receiving element is controlled by the controller54. The RF generator 51 is electrically connected to the controllerthrough conductors 55 and 56 and preferably operates at about 300 toabout 1000 KHz, specifically, about 700 to about 900 KHz and has a poweroutput of about 50 to about 150 watts, preferably, about 80 to about 100watts. Vacuum is generated by the vacuum pump 57 which is connected in afluid flow relationship with the inner lumen (not shown) provided inconduit 58 which leads to a vacuum trap 59. Vacuum is applied to theinner lumen 22 of the probe member 11 through inner lumen 36 ofconnection member 23 connected to the vacuum trap. A meter actuation andcontrol cable 60 is provided to power and control the actuation elementsin handle 15.

A patient's skin must be breached in order to gain access to a body sitewhere a tissue specimen is to be obtained. A scalpel or other surgicalinstrument may be used to make an initial incision in the skin; somephysicians may prefer to first make an incision with a scalpel throughthe patient's skin and expose subcutaneous tissue before passing thedevice 10 through the tissue. Alternatively, access through the skin maybe achieved without such an initial incision by pressing the energizedtissue-cutting electrode 13 of the device 10 against an exterior site onthe patient's skin proximate to the tissue site where a tissue specimenis to be obtained. High frequency electrical power from the generator 51passes through the electrical conductor 41 to energize thetissue-cutting electrode 13.

Once the skin is breached by any suitable means, the device 10, with thetissue-cutting electrode 13 energized is advanced through the tissueuntil the distal end 21 of the device 10 has passed through the tissuewhich is to form the specimen. The cutting action of the energizedtissue-cutting electrode 13 forms a planar cut through the desiredtissue bed and allows the probe 11 to readily pass through the tissue.Very little collateral tissue damage at the margins where the tissue cutis made is done by the tissue-cutting electrode 13 as tissue isaccessed. The device 10 is preferably advanced through the patient'stissue to the specimen site with the supporting tube 14 in a closedconfiguration, the supporting tube 14 covering distal extremity 20 ofprobe 11.

Once the device 10 is in the desired location, the supporting tube 14can be withdrawn to an opened configuration to expose the distalextremity 20 of the probe 11 by action of the driver (not shown)operatively connected to the arm 28 of collar 27. With the distalextremity 20 of the probe 11 exposed, a vacuum can be generated withinthe inner lumen 22 of probe 11 by the action of vacuum pump 57. Thevacuum generated in the inner lumen 22, acting through the ports 25 inthe distal extremity 20 draws tissue at the site against the surface ofthe distal extremity 20 and holds the tissue against that surface asshown in FIG. 16. The tissue-cutting blade 12 may then be drivendistally along with the supporting tube 14 to which the tissue-cuttingblade 12 is secured, effective to sever a generally cylindrical shapedtissue specimen 61 from the adjacent tissue site and cover the severedtissue specimen with the supporting tube 14 as shown in FIG. 17.

In preferred embodiments of methods and devices embodying features ofthe invention, tissue-cutting blade 12 rotates, preferably at highspeed, during its distal translation as it severs tissue from thesurrounding tissue bed. Such rotation may be in a single rotationaldirection, or may alternate between clockwise and counter-clockwiserotation. Tissue-cutting blade 12 may also reciprocate longitudinally,with or without rotation, during distal translation as it severs tissuefrom the surrounding tissue bed. Access cannula 19 acts to protectsurrounding tissue from damage during translation, rotation, and/orreciprocation of the supporting tube 14 and tissue-cutting blade 12.

The biopsy device may be removed from the patient after a tissue samplehas been collected, and the sample removed for inspection and analysis.The entire device 10 may be removed; however, in preferred embodiments,portions of the device may remain within a patient's body to aid, forexample, in the acquisition of further tissue specimens and in theplacement of markers at the site from which a tissue sample was taken.For example, the supporting tube 14 and probe 11 may be withdrawntogether from within access cannula 19, the supporting tube 14 remainingin a closed configuration outside of probe 11 and helping, along withthe vacuum, to hold the tissue sample. Re-introduction of probe 11 andsupporting tube 14 within access cannula 19 (which remains in placewithin a patient's body) allows further samples to be taken. The accesscannula 19 serves as a guide for re-introduction of the remainder of thedevice 10 and aids in obtaining subsequent tissue samples.Alternatively, the probe 11 may be removed, with a tissue sample held byvacuum, from within the supporting tube 14, while supporting tube 14 andaccess cannula 19 remain in place within the patient's body.Re-introduction of probe 11 within supporting tube 14 allows furthersamples to be taken.

Such further samples may be from the same location, or from differentlocations. Where subsequent samples are taken from the same location asa previous sample, so that the tissue-cutting electrode 13 need not beactivated (since the pathway to the body location has already beenformed), further application of vacuum draws tissue near to theelongated probe, where the tissue may be separated from adjacent bodytissue by the tissue-cutting blade 12. Due to the planar cut made by thetissue-cutting electrode 13 through the tissue from which the specimenis to be obtained, the initial cylindrical specimen 61 is typically asplit specimen which greatly aids in its evaluation. Although theinitial samples are typically split samples, subsequent samples takenfrom the same location are typically not split samples.

Access cannula 19 exterior to the supporting tube 14 can be left in thepatient with its distal end at the site from which the specimen wasobtained in order to provide access to the site at a later time. Accesscannula 19 may thus be used to allow a marker or other device to bedeposited at the site, or to guide further procedures or treatments atthe site as necessary or desirable. After the biopsy procedure iscompleted, the incision formed by the initial cut through the patient'sskin may be appropriately closed.

An alternative probe member 70 embodying features of the invention isdepicted in FIGS. 18 and 19. In this alternative the distal extremity 71of the probe device 70 is of tubular construction as shown. Thetissue-cutting electrode 72 on the enlarged distal end 74 of the distalextremity 71 of the probe member 70 has an expandable construction whichis disclosed in copending application Ser. No. 09/477,255,filed Jan. 4,2000,entitled Apparatus and Method for Accessing A Biopsy Site, byBurbank et al., which is incorporated herein by reference in itsentirety. The tubular distal extremity 71 has a plurality of ports 73which are in fluid communication with an inner lumen 75. Tissue-cuttingelectrode 72 is secured to the enlarged distal end 74. A proximalenlargement 77 is disposed proximally of the distal extremity 71 on theprobe member 70. An electrical conductor 76 (shown in FIG. 19) extendsthrough inner lumen 75 and is electrically connected to electrode 72. Asupporting tube 78 carrying a circular cutter 79 extends about the probemember 70 within access cannula 80. The probe 70 is used with accessingcannula 80, supporting tube 78 and circular tissue-cutting blade 79 inthe same manner as described above for the embodiment shown in FIGS.1–14. The supporting tube 78 may be configured to allow the probe 70 tobe withdrawn with the specimen for specimen removal leaving the distalend of the accessing cannula located at the biopsy site.

A cross-sectional view of a device 70 having an expandabletissue-cutting electrode 72 embodying features of the invention is shownin FIG. 20, with the access cannula 80 shown in a closed configuration.Supporting tube 78 circular cutter 79 are shown in a distally-disposed,closed configuration (dark lines) and in a proximally-disposed, openconfiguration (dotted lines) within access cannula 80, which acts as asheath to enclose the inner elements of the device 70, particularly whenit is in its distally-disposed, closed configuration.

The use of such a device 70 is illustrated in FIGS. 21A–21F, whichillustrate a method of using an apparatus for accessing a body sitehaving features of the invention. For example, the apparatus may befirst inserted into a patient's body using radiofrequency energy appliedvia the tissue-cutting electrode; the access cannula and tissue-cuttingblade may be retracted, followed by application of vacuum; thetissue-cutting blade and access cannula may be advanced though tissue tocut a sample; the sample may then be removed along with thetissue-cutting blade and tissue-cutting electrode, leaving the accesscannula in place; the sample may be removed from the apparatus (with thevacuum turned off) by retracting the supporting tube and tissue-cuttingblade; and then the supporting tube, tissue-cutting blade, andtissue-cutting electrode may be re-inserted within the access cannulafor removal of further samples.

As illustrated in FIGS. 21A–21F, a first step in obtaining a tissuesample, or in obtaining several tissue samples, from a location within apatient's body, includes inserting a device 70 into a patient's body. Adevice 70 may be inserted into a patient's body in a configuration asillustrated in FIG. 21A, with distal cutter 72 activated with RF energyto cut through tissue. Access cannula 80 is disposed distally in aclosed configuration, with supporting tube 78 and circular cutter 79proximally disposed in an open configuration within the access cannula80. Alternatively, supporting tube 78 and circular cutter 79 may bedistally disposed within the access cannula 80. If desired, a scalpel orother sharp instrument may be used to make an initial incision through apatient's skin 81; however, the initial incision and subsequentadvancement of the device into a patient's body may be done solely usinga distal cutter 72 under RF power. In preferred embodiments, thecircular cutter 79 and access cannula 80 move together, remaining in theconfiguration shown in FIG. 21 C.

In a second step, access cannula 80 may be retracted (or probe 71extended distally into a patient's body tissue) to obtain theconfiguration illustrated in FIG. 21B. In this configuration, probe 71extends distally of access cannula 80, circular cutter 79 and supportingtube 78, exposing ports 73 to surrounding tissue. Vacuum, such as may besupplied by a vacuum system with a vacuum source, may be applied viaports 73 to urge tissue into contact with the distal extremity 71 of theprobe member 70.

A further step in a method obtaining a tissue sample, or in obtainingseveral tissue samples, from a location within a patient's body isillustrated in FIG. 21C. Circular cutter 79, followed by access cannula80, may be advanced into surrounding tissue by distal movement arounddistal extremity 71 effective to sever tissue from the surroundingtissue bed. This may result in a split tissue sample (split due to theaction of distal cutter 72 as device 70 is inserted into a desiredlocation within a patient's body) disposed within supporting tube 78 andpreferably held against distal extremity 71 by action of vacuum. Thus,after advancement of the supporting tube and access cannula, as shown inFIG. 21C, a tissue sample is held within device 70 for removal from apatient.

Tissue removal may be performed as illustrated in FIG. 21D. Portions ofa device 70, including a distal extremity 71, a supporting tube 78, anda circular cutter 79, and a tissue sample held within supporting tube 78and circular cutter 79, may be removed proximally by withdrawing themfrom within an accessing cannula 80, which remains in place at leastpartially within a patient's body.

The tissue sample may be removed from the device outside the patient'sbody for investigation, analysis and storage as desired. As shown inFIG. 21E, portions of the device 70 may be configured for removal of atissue sample by retraction of the supporting tube 78 and circularcutter 79 to expose the tissue sample, and by closing the vacuumconnection between ports 73 and a vacuum system with a vacuum source.

The accessing cannula 80 provides a guide for re-insertion of portionsof the device 70 that have been removed from the patient, as illustratedin FIG. 21F. The device 70 is shown in FIG. 21F after re-insertion intoa patient's body in a configuration for recovery of another tissuesample. As the configuration in FIG. 21F is the same as that in FIG.21A, it will be understood that subsequent tissue samples may beacquired by steps described above and as illustrated in FIGS. 21B andthe following figures. Alternatively, if no further samples are desired,the accessing cannula 80 may be removed after the steps illustrated inFIG. 21E and standard post-operative care provided to the patient.

In addition to suction ports 25, the distal extremity 20 (and optionallythe supporting tube 14) may have features configured to retain a tissuesample. For example, a distal extremity 20 may include radial elementsconfigured to engage and retain tissue, such as hooks, barbs, hairs, orprobes, that may grab and/or puncture tissue of an adjacent tissuesample. Such radial elements may be angled to be other thanperpendicular to a longitudinal axis of probe 11 (e.g., angled to pointpartially in a distal direction), so that a tissue specimen is retainedduring distal movement of the probe 11.

In addition, tissue-cutting electrode may be configured to be able toretract or otherwise reduce its radial extent before being removedproximally through supporting tube 14 during recovery of a tissuespecimen. Such retraction is effective to reduce the possibility ofdamage to a tissue-cutting blade 12 as the tissue-cutting electrode 13is withdrawn. Similarly, the possibility of damage to an access cannula19 is reduced by retraction of a tissue-cutting electrode 13 beforewithdrawal of a probe 11 through the access cannula 19. The radialextent of a tissue-cutting electrode 13 may be reduced by, for example,retracting a central supporting portion of a tissue-cutting electrode ofthe type illustrated in FIG. 18, or by retracting a distal supportingportion of a tissue-cutting electrode of the type illustrated in FIG. 1.Such retraction may be effected by proximal movement of a connectingelement attached to such supporting elements. For example, such aconnecting element may be, or may be connected to, an electricalconductor 41 or 76.

Those skilled in the art will recognize that various modifications maybe made to the specific embodiments illustrated above. In addition, itwill be readily appreciated that other types of instruments may beinserted into the tissue site through the supporting tube or a suitablecannula in addition to or in place of the instruments described above.These and other modifications that may suggest themselves are consideredto be within the scope of the claims that follow.

1. An biopsy system for separation of a tissue specimen from a targettissue site and collection of the separated tissue specimen, comprising:a. a handle having a recess in a surface thereof; and b. a biopsy devicecomprising i. a housing configured to fit within the recess provided inthe housing, ii. an elongated probe which has a proximal end disposedwithin the housing, a distal end, an inner lumen extending within theprobe and which has a distal extremity with a plurality of apertures ina wall thereof that is in fluid communication with the inner lumenextending within the probe and with a small transverse dimension lessthan portions of the probe distal to the distal extremity; and iii. atissue-cutting blade which is at least partially disposed about theelongated probe, which lies in a plane traversing the longitudinal axisof the probe, which has an inner dimension greater than the smalltransverse dimension of the distal extremity of the probe, and which issecured to a driving member configured for longitudinal movement along alength of the distal extremity of the probe, and iv. a vacuum tube whichhas an inner lumen, which has a distal end connected in fluidcommunication with the inner lumen of the probe member and which has aproximal end configured to be secured to a vacuum source.
 2. The systemof claim 1 wherein the probe has a tissue penetrating electrode on thedistal end there.
 3. The system of claim 2 wherein the biopsy device hasan electrical conductor with a distal end electrically connected to theelectrode and a proximal end configured to be electrically connected toa high frequency, electrical power source.
 4. The system of claim 2including a control module which has a high frequency power sourceconfigured to be electrically connected to the proximal end of theelectrical conductor of the biopsy device.
 5. The system of claim 2wherein the tissue-penetrating electrode has an arcuate shape and has achord length at least as great as the transverse dimension of the distalend of the probe.
 6. The system of claim 5 wherein thetissue-penetrating electrode at least in part lies in a plane which isparallel to a longitudinal axis of the probe.
 7. The system of claim 5wherein the arcuate tissue-cutting electrode has an expanded deployedconfiguration with a width greater than an outside transverse dimensionof the distal end of the probe and a contracted configuration with awidth that is equal to or less than an inside transverse dimension ofthe inner lumen of the outer tubular member.
 8. The system of claim 5wherein the arcuate tissue-cutting electrode is spaced distally of thedistal end of the elongated inner probe.
 9. The system of claim 1including a control module which has a vacuum source configured to beconnected in fluid communication with the proximal end of the vacuumtube.
 10. The system of claim 1 wherein the driving member is configuredto be operably connected to a source of mechanical power for impartinglongitudinal movement and rotational movement thereto.
 11. The system ofclaim 1 wherein the distal extremity of the probe has a circulartransverse cross-sectional shape.
 12. The system of claim 1 including asupporting tube which has proximal and distal ends, which has an innerlumen extending therein, which is slidably disposed about the elongatedprobe member and which is configured to be advanced over the distalextremity and thereby capture any tissue adjacent the distal extremity.13. The system of claim 12 wherein the tissue-cutting blade is at thedistal end of the supporting tube.
 14. The system of claim 12 includingan accessing cannula disposed around at least part of the supportingtube.
 15. The system of claim 1, wherein the driving member for thetissue-cutting blade is configured to reciprocate longitudinally duringdistal movement around the probe.
 16. The system of claim 1 wherein thedriving member is configured for longitudinal movement and rotationalmovement along a length of the distal extremity of the probe.
 17. Thesystem of claim 1 where In the vacuum tube is flexible.